(6)
Prescription
information reduced to writing from an order received by telephone, facsimile,
or recording device.

(B)
Records of dispensing must provide accountability and ensure that patients do
not receive more drugs than intended by the prescriber.

(C)
All records relating to the practice of
pharmacy shall be uniformly maintained for a period of three years, be readily
available, and promptly produced upon request for inspection by a state board
of pharmacy officer, agent, and/or inspector during regular business
hours.

(D)
All prescriptions or
other records relating to the practice of pharmacy, which are required to be
kept for three years according to section
4729.37 of the Revised Code, may
be microfilmed or placed on electronic, magnetic media. The microfilm or
electronic, magnetic media used for this purpose must comply with the
"International Standards Organization" standards of quality approved for
permanent records. Such records are subject to all other paragraphs of this
rule.

(E)
Any pharmacy intending to
maintain records relating to the practice of pharmacy at a location other than
the place licensed with the state board of pharmacy must first send written
notification to the state board of pharmacy. The request shall contain the
terminal distributor of dangerous drug name and license number of the requestor
and the name and address of the alternate location. The state board of pharmacy
office will send written notification of the approval or denial of the request.
A copy of the board's approval shall be maintained with other records relating
to the practice of pharmacy. Any such alternate location shall be secured and
accessible only to representatives of the terminal distributor of dangerous
drugs.

(F)
Alternate record keeping
systems include, but are not limited to, the following:

(1)
A system that utilizes the original hard
copy prescription to document the initial dispensing of a prescription, but
utilizes a computerized system to dispense refills that does not document the
positive identification of the pharmacist responsible for the practice of
pharmacy. In order to document positive identification, this system would
require the manual signature or initials of a pharmacist on a hard copy record
as indicated in paragraph (I) of this rule.

(2)
A computerized system that documents the
positive identification of the pharmacist responsible for the practice of
pharmacy. If this method is used, it must be approved by the board and provide
a daily backup.

(G)
All computerized record keeping systems
must be capable of providing immediate retrieval (via
digital
display and hard copy printout or other mutually agreeable transfer medium) of
patient profile information for all prescriptions filled within the previous
twelve months and retrieval within three working days, excluding weekends and
holidays, of all prescriptions dispensed within the previous three years. This
information shall include at least, but is not limited to, the following data:

(9)
If
utilizing a board approved system pursuant to paragraph (F)(2) of this rule,
there must be positive identification documented within the system of the
pharmacist responsible for prescription information entered into the computer
system, the pharmacist responsible for prospective drug utilization review as
defined in rule
4729-5-20 of the Administrative
Code, and the pharmacist responsible for dispensing;

(5)
If utilizing a board
approved system pursuant to paragraph (F)(2) of this rule, there must be
positive identification documented within the system of the pharmacist
responsible for prospective drug utilization review as defined in rule
4729-5-20 of the Administrative
Code and the pharmacist responsible for dispensing for each refill;

(6)
The total number of refills dispensed to
date for that prescription order.

(I)
Hard copy documentation as required
pursuant to paragraph (F)(1) of this rule must be provided by each individual
pharmacist who makes use of such system by one of the following methods:

(1)
A hard copy printout of each day's
prescription refill data that shall include, at a minimum, the following data:

This printout must be verified, dated, and signed by each
individual pharmacist who dispensed a prescription that day. The pharmacist
must verify that the data on the printout is complete and correct and sign a
statement to that effect on the document as he/she would sign a check or legal
document (e.g., J. H. Smith or Jane H. Smith). These documents must be
maintained in chronological order in a separate file at the licensed location
where the drug was dispensed for a period of three years from the date of
dispensing. If the printout is prepared at a location other than that where the
drug was dispensed, the printout must be provided to the licensed location
within three working days, excluding holidays and weekends, of the date on
which the drugs were dispensed. Such printouts must be verified and signed by
each pharmacist who dispensed drugs within twenty-four hours of the date the
printout is received;

(2)
A tamper evident log book in which shall
be entered, at a minimum, the date of dispensing and prescription number. The
dispensing pharmacist must manually record his/her name or initials on each log
book entry at the time of dispensing each refill; or

(3)
Each individual pharmacist involved in
dispensing drugs must enter into a tamper evident log book, at a minimum, the
following data for each prescription refilled:

Each individual pharmacist involved in dispensing drugs must
review this information at the end of each day and then must sign a statement
in the log book attesting to the fact that the prescription information entered
into the computer that day and recorded in the log book has been reviewed by
him/her and is correct as shown.

(J)
In addition to the immediate retrieval
and production of patient profile information required by paragraph (G) of this
rule, a pharmacy that utilizes a computerized record keeping system must be
able to:

(a)
An electronic record in a
character-delimited or fixed-width ASCII text file or other mutually acceptable
format that contains any requested data fields the user pharmacy is responsible
for maintaining pursuant to all federal and state laws, rules and regulations;
and

(b)
A hardcopy printout sorted
by any requested data fields that the user pharmacy is responsible for
maintaining pursuant to all federal and state laws, rules, and
regulations.

(2)
Provide, within three working days of a request by an individual authorized by
law to access such records, any requested:

(b)
Electronic record
and a definition file describing the file layout and column width, if
applicable.

(K)
In the event that the computerized record
keeping system experiences down time, a record of all refills dispensed during
such time must be recorded on the back of the original prescription. The refill
information must be entered into the computerized record keeping system as soon
as it is available for use. During the time the computerized record keeping
system is not available, prescriptions may be refilled only if, in the
professional judgment of the pharmacist, the number of refills authorized by
the prescriber has not been exceeded.

(L)
A pharmacy purging a computerized record
keeping system of prescription records must develop a method of record keeping
capable of providing retrieval (via digital display, hard copy printout, or
other mutually agreeable transfer medium) within three working days, excluding
holidays and weekends, of prescription order information for all prescriptions
filled or refilled within the previous three years. This information shall
include, at a minimum, the following data:

(M)
A log must be maintained of all changes
made to a prescription record after the prescription has been dispensed. Such
log may be accessible to the pharmacist for review, but shall be protected from
being altered in any way. The log must contain at least, but is not limited to,
the following:

(3)
There is
positive identification, in the computer system or on the hard copy
prescription, of the pharmacist who is responsible for entering the
prescription information into the system; and

(4)
The original prescription is filed
according to rule
4729-5-09 of the Administrative
Code.

(O)
Records shall
be maintained for three years on all immunizations administered pursuant to
section 4729.41 of the Revised Code and
rule 4729-5-38 of the Administrative
Code and must include at least the following information:

(10)
Positive
identification of the administering pharmacist or the administering pharmacy
intern and supervising pharmacist;

(11)
Positive identification of the patient,
parent, or legal guardian of the patient who gives informed consent to
administer an immunization.

(P)
A pharmacist or pharmacy intern under the
direct supervision of a pharmacist who administers an immunization pursuant to
section 4729.41 of the Revised Code and
rule 4729-5-38 of the Administrative
Code shall maintain and immediately make available, upon the request of the
state board of pharmacy, the following records:

(1)
Documentation of the successful
completion of a board approved course in the administration of
immunizations;

(2)
Documentation of
current certification to perform basic life support procedures pursuant to
division (B)(2) of section
4729.41 of the Revised
Code.